Journal of medical ethics
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Journal of medical ethics · May 2015
Analysis of warning letters issued by the US Food and Drug Administration to clinical investigators, institutional review boards and sponsors: a retrospective study.
The US Food and Drug Administration (FDA) issues warning letters to all research stakeholders if unacceptable deficiencies are found during site visits. Warning letters issued by the FDA between January 2011 and December 2012 to clinical investigators and institutional review boards (IRBs) were reviewed for various violation themes and compared to similar studies in the past. Warning letters issued to sponsors between January 2005 and December 2012 were analysed for the first time for a specific set of violations using descriptive statistics. ⋯ Failure to maintain minutes of meeting and to follow written procedures for continuing review were new substantial violations in warning letters issued to IRBs. Forty-six warning letters were issued to sponsors, the most common violations being failure to follow a monitoring schedule (58.69%), failure to obtain investigator agreement (34.78%), failure to secure investigators' compliance (30.43%), and failure to maintain data records and ship documents to investigators (30.43%). Appropriate methods for handling clinical trial procedural violations should be developed and implemented worldwide.
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Journal of medical ethics · May 2015
What would an environmentally sustainable reproductive technology industry look like?
Through the use of assisted reproductive technologies (ARTs), multiple children are born adding to worldwide carbon emissions. Evaluating the ethics of offering reproductive services against its overall harm to the environment makes unregulated ARTs unjustified, yet the ART business can move towards sustainability as a part of the larger green bioethics movement. By integrating ecological ethos into the ART industry, climate change can be mitigated and the conversation about consumption can become a broader public discourse. ⋯ First, endorsing a carbon capping programme that limits the carbon emissions of ART businesses will be proposed. Second, I will recommend that policymakers eliminate funded ARTs for those who are not biologically infertile. I will conclude the article by urging policymakers and all those concerned with climate change to consider the effects of the reproductive technologies industry in light of climate change and move towards sustainability.
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Disaster planning challenges our morality. Everyday rules of action may need to be suspended during large-scale disasters in favour of maxims that that may make prudential or practical sense and may even be morally preferable but emotionally hard to accept, such as tsunami-tendenko. This maxim dictates that the individual not stay and help others but run and preserve his or her life instead. ⋯ While tsunami-tendenko has been praised, two criticisms of it merit careful consideration: one, that the maxim is selfish and immoral; and two, that it goes against the natural tendency to try to save others in dire need. In this paper, I will explain the concept of tsunami-tendenko and then respond to these criticisms. Such ethical analysis is essential for dispelling confusion and doubts about evacuation policies in a disaster.